Teleflex Medical Recalls Surgical Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of surgical sutures because the needles may detach from the suture during use, failing to meet minimum strength requirements.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (needle detachment) that poses a risk of harm during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 32,271 units of various surgical sutures, including Polypropylene, CAPIO, Deklene II, and Deklene MAXX products. The recall was initiated because the affected products do not meet minimum needle attachment strength requirements. This defect means the needle can become detached from the suture during use.
The affected products were distributed worldwide, including in the United States (specifically in states such as AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI) and in Canada, Germany, and Ireland. The products are indicated for use in soft tissue approximation.
Healthcare providers and patients should stop using the affected lots immediately. The specific product codes and lot numbers are listed in the official recall notice. Users should contact Teleflex Medical or their supplier for further instructions on how to return or replace the affected products.
The recalled product
- Product
- Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, B
- Manufacturer
- Teleflex Medical
- Affected units
- 32,271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code 833-123 - Lot 02A0902858
- 02D0900775
- 02G1003092
- 02H1100535
- 02H1100536
- 02K1102309
- Product Code 833-124 - Lot 02A1200503
- 02B1101450
- 02C0903400
- 02D0900010
- 02D0900103
- 02D1003285
- 02D1003286 02F1302321
- 02G1000045
- 02G1300348
- 02G1301122
- 02H1100494
- 02L0803407
- 02L1100009
- 02M1002289
Distribution
Part of a larger recall action
This product is one of 7 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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